Medical electrical lead

ABSTRACT

A medical device lead is presented. The lead includes one or more jacketed conductive elements. The jacket comprises one or more covers. A first cover of polyether ketone (PEEK) is in direct contact with the at least one conductive element. At least one conductive element and a PEEK cover are coiled. The coiled conductive element can substantially retain its original coiled shape.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims priority and other benefits from U.S.Provisional Patent Application Ser. No. 60/973,479 filed Sep. 19, 2007,incorporated herein by reference in its entirety. The presentapplication also claims priority and other benefits from U.S.Provisional Patent Application Ser. No. 60/972,114 filed Sep. 13, 2007,incorporated herein by reference in its entirety.

TECHNICAL FIELD

The disclosure relates to implantable medical devices and, moreparticularly, to implantable medical leads.

BACKGROUND

The human anatomy includes many types of tissues that can eithervoluntarily or involuntarily, perform certain functions. After disease,injury, or natural defects, certain tissues may no longer operate withingeneral anatomical norms. For example, after disease, injury, time, orcombinations thereof, the heart muscle may begin to experience certainfailures or deficiencies. Certain failures or deficiencies can becorrected or treated with implantable medical devices (IMDs), such asimplantable pacemakers, implantable cardioverter defibrillator (ICD)devices, cardiac resynchronization therapy defibrillator devices, orcombinations thereof.

IMDs detect and deliver therapy for a variety of medical conditions inpatients. IMDs include implantable pulse generators (IPGs) orimplantable cardioverter-defibrillators (ICDs) that deliver electricalstimuli to tissue of a patient. ICDs typically comprise, inter alia, acontrol module, a capacitor, and a battery that are housed in ahermetically sealed container with a lead extending therefrom. It isgenerally known that the hermetically sealed container can be implantedin a selected portion of the anatomical structure, such as in a chest orabdominal wall, and the lead can be inserted through various venousportions so that the tip portion can be positioned at the selectedposition near or in the muscle group. When therapy is required by apatient, the control module signals the battery to charge the capacitor,which in turn discharges electrical stimuli to tissue of a patientthrough via electrodes disposed on the lead, e.g., typically near thedistal end of the lead. Typically, a medical electrical lead includes aflexible elongated body with one or more insulated elongated conductors.Each conductor electrically couples a sensing and/or a stimulationelectrode of the lead to the control module through a connector module.It is desirable to develop implantable medical electrical leads with newlead body subassemblies.

BRIEF DESCRIPTION OF DRAWINGS

Aspects and features of the present invention will be appreciated as thesame becomes better understood by reference to the following detaileddescription of the embodiments of the invention when considered inconnection with the accompanying drawings, wherein:

FIG. 1 is a conceptual schematic view of an implantable medical devicein which a medical electrical lead extends therefrom;

FIG. 2 is a schematic view of a medical electrical lead;

FIG. 3A is a schematic view of a distal end of the medical electricallead;

FIG. 3B is a cross-sectional view taken along plane A-A of the distalend of the medical electrical lead depicted in FIG. 3A;

FIG. 4A is a schematic view of a jacket that surrounds one or moreconductive elements in a medical electrical lead;

FIG. 4B is a schematic sectional view of the jacket depicted in FIG. 4A;

FIG. 5A is a schematic view of an exemplary insulated conductiveelement;

FIG. 5B is a cross-sectional view of the insulated conductive elementdepicted in FIG. 5A;

FIG. 6A is a schematic view of an exemplary insulated multi-conductorelement;

FIG. 6B is a schematic cross-sectional view of an exemplary insulatedmulti-conductor element depicted in FIG. 6A;

FIG. 7A is a schematic view of another exemplary insulatedmulti-conductor element;

FIG. 7B is a schematic cross-sectional view of an exemplary insulatedmulti-conductor element depicted in FIG. 7A;

FIG. 8A is a schematic view of an exemplary insulated multi-conductorelement before its stretched;

FIG. 8B is a schematic view of an exemplary insulated multi-conductorelement being stretched;

FIG. 8C is an exemplary insulated multi-conductor element in a relaxedposition and returning to its original coiled shape;

FIG. 9 is a schematic view of an exemplary insulated multi-conductorelement wrapped around a tubular insulative element or a coil liner;

FIG. 10A is a schematic view of yet another exemplary insulatedmulti-conductor element wrapped around a mandrel;

FIG. 10B is a cross-sectional view of the insulated conductive elementdepicted in FIG. 10A; and

FIG. 11 is a flow diagram for forming a coiled jacketed conductiveelement.

DETAILED DESCRIPTION

The present disclosure relates to a medical electrical lead thatincludes a lead body. The lead body comprises at least one elongatedconductive element, such as a cable, surrounded by an elongated jacket.The jacket can include one or more covers. The jacket can be formedthrough an extrusion process directly over the conductive element, whichreduces or eliminates diametrical expansion of the coiled conductiveelement which can occur due to elastic “springback” or stress relaxationof the coiled composite structure. A first cover comprisespolyetherether ketone (PEEK) extruded directly over the conductiveelement. In one embodiment, the conductive element and the jacket, isthen formed into a coil.

In another embodiment, a jacket or one or more longitudinal elements areformed by a first cover of PEEK that is directly adjacent to aconductive element. A second cover of polymeric material is placed overthe first cover. The second cover comprises a polymer such as PEEK,ethylene-tetrafluoroethylene (ETFE), e-beam cross-linked ETFE,fluorinated ethylene propylene (FEP), perfluoroalkoxy (PFA),ethylene-tetraflouroethylene based copolymer (EFEP), silicone,polyurethane, or polyurethane-silicone copolymers.

In one embodiment, the PEEK undergoes a molecular mobility process priorto or during introduction of the PEEK over an elongated conductiveelement. Exemplary molecular mobility processes can include thermalannealing, stress relieving, or other suitable means for a material toachieve a more flexible molecular structure.

Thermal processing can involve exposing the composite structure to acontrolled heating and cooling schedule. Suitable temperatures candepend upon the type of polymeric material and/or number of covers orlayer(s) employed, to form a jacket, a composite jacket, or one or morelongitudinal elements that can house conductive elements. PEEK, forexample, can be thermally processed at about 130-200 degrees Celsius (°C.). Thermal processing of PEEK onto an elongated conductive elementcauses the conductive element to substantially maintain a controlledpitch and diameter after coiling. For example, a conductive element suchas a cable in a coil shape can substantially maintain up to about 99percent of its original coil shape, after the conductive element hasbeen released from, for example, a mandrel which is after a thermalprocessing has been performed. The final diameter and pitch of a coilshape is generally based upon the coil composite structure and itselastic “springback” or coil expansion from stress relaxation, thewinding diameter/pitch, and the processing parameters used to set thecoil shape. In one embodiment, a coiled cable is more resistant to flexfatigue compared to a linear or straight cable. Additionally, smallercoiled cable diameters are achieved through application of theprinciples described herein. In one embodiment, about 10 percent or moreof a diameter reduction in the coiled conductive element is achievedthrough the principles described herein. In another embodiment, about 5percent or more diameter reduction is achieved in the coiled conductiveelement through the principles described herein. In still yet anotherembodiment, about 2 percent or more diameter reduction is achieved inthe coiled conductive element through the principles described herein.Smaller coiled cable diameters allow for smaller sized leads to beproduced. Smaller sized leads can include 7 French or smaller. Inanother embodiment, smaller sized leads can include 6 French or smaller.In still yet another embodiment, smaller sized leads can include 5French or smaller. Reduction in coiled cable diameters and the lead bodysize through the use of extruded PEEK was unexpected since it isdesirable to attain thin polymeric walls and PEEK, a material thatpossesses a relatively high melting point, a high modulus, and is veryviscous, can be difficult to extrude, compared with most otherthermoplastic polymers.

The principles described herein are applicable to all types of medicalelectrical leads. For example, the disclosure applies to cardiovascularleads (e.g. high voltage leads, low voltage leads etc.), neurologicalleads, or other suitable applications.

FIG. 1 depicts a medical device system 100. A medical device system 100includes a medical device housing 102 having a connector module 104(e.g. international standard (IS)-1, defibrillation (DF)-1, IS-4 etc.)that electrically couples various internal electrical components housedin medical device housing 102 to a proximal end 105 of a medicalelectrical lead 106. A medical device system 100 may comprise any of awide variety of medical devices that include one or more medical lead(s)106 and circuitry coupled to the medical electrical lead(s) 106. Anexemplary medical device system 100 can take the form of an implantablecardiac pacemaker, an implantable cardioverter, an implantabledefibrillator, an implantable cardiacpacemaker-cardioverter-defibrillator (PCD), a neurostimulator, a tissueand/or muscle stimulator. IMDs are implanted in a patient in anappropriate location. Exemplary IMDs are commercially available asincluding one generally known to those skilled in the art, such as theMedtronic CONCERTO™, SENSIA™, VIRTUOSO™, RESTORE™, RESTORE ULTRA™, soldby Medtronic, Inc. of Minnesota. Non-implantable medical devices orother types of devices may also utilize batteries such as external drugpumps, hearing aids and patient monitoring devices or other suitabledevices. Medical device system 100 may deliver, for example, pacing,cardioversion or defibrillation pulses to a patient via electrodes 108disposed on distal end 107 of one or more lead(s) 106. Specifically,lead 106 may position one or more electrodes 108 with respect to variouscardiac locations so that medical device system 100 can deliverelectrical stimuli to the appropriate locations.

FIG. 2 depicts lead 106. Lead 106 includes a lead body 117 that extendsfrom proximal end 105 to a distal end 107. Lead body 117 can include oneor more connectors 101, and one or more jacketed conductive elements 112a-d. A jacket (also referred to as a liner, longitudinal element,coating) extends along and longitudinally around the conductive elements112 a-d and can serve to contain or mechanically constrain one or moreconductive elements 112 a-d. A jacket can also insulate one or moreconductive elements 112 a-d. Connector module 104 can contain connectors122, such as set screws, serve to electrically and mechanically connectconductive elements 112 a-d to ports (not shown) of connector module104. Conductive element 112 c (also referred to as a “conductor coil,”torque coil”, “distal tip conductor”) can extend to the distal end 107and can optionally be coupled to a retractable and/or extendable helicaltip. One or more conductive elements 112 a,b serve as, or are connectedto, defibrillation coils 103 a,b that deliver electrical stimuli, whennecessary, to tissue of a patient. Lead 106 can also include aconductive element 112 d that extends from the proximal end 105 to ringelectrode 118 while another conductive element 112 c extends fromproximal end 105 to tip electrode 120.

Electrically conductive elements 112 a-d can include coils, wires, coilwound around a filament, cables, conductors or other suitable members.Conductive elements 112 a-d can comprise platinum, platinum alloys,titanium, titanium alloys, tantalum, tantalum alloys, cobalt alloys(e.g. MP35N, a nickel-cobalt alloy etc.), copper alloys, silver alloys,gold, silver, stainless steel, magnesium-nickel alloys, palladium,palladium alloys or other suitable materials. Electrically conductiveelement 112 a-d is covered, or substantially covered, longitudinallywith a jacket 130 (also referred to as a liner, a longitudinal element,a longitudinal member, a coating, a tubular element, a tube or acylindrical element). In yet another embodiment, each conductive element112 a-d is surrounded by a tubular element, which can possess a circularor a non-circular cross-section. An outercover or outerjacket in a leadbody 117 can exhibit a non-circular cross-section.

Typically, the outer surface of electrodes 108 such as the ringelectrode 118, the tip electrode 120, and the defibrillation coils 103a,b are exposed or not covered by a jacket 130 or liner so thatelectrodes 108 can sense and/or deliver electrical stimuli to tissue ofa patient. A sharpened distal tip (not shown) of tip electrode 120facilitates fixation of the distal end of helically shaped tip electrode120 into tissue of a patient.

Referring to FIGS. 3A-3B, and 4A-4B, lead body 117 can include one ormore jackets 130 and one or more conductive elements 112 a,b,d. In oneembodiment, lead body 117 comprises one or more jackets 130 disposed inanother jacket 130. In still yet another embodiment, lead body 117comprises one or more jackets 130 with an outer cover 140 that surroundsthe one or more jackets 130.

Each jacket 130 can include one or more covers, as depicted in FIGS.4A-4B with cross-sectional segment 128. Each cover 146, 148, 150, and152 can comprise one or more layers of polymeric compounds. Numerousembodiments of jacket 130 or liner are summarized in Table 1 anddescribed in greater detail below. The first embodiment listed in Table1 involves a single cover or first cover 144 of PEEK such that the innerlumen of first cover 144 is adjacent to a conductive element 112 a,b,d,a delivery device (not shown) such as a guide wire or stylet, or a lumenwithout a delivery device, or a conductive element 112 c such as aconductor coil. PEEK is commercially available as Optima from Invibiolocated in Lancashire, United Kingdom. The first cover 144 of PEEK canbe formed in a variety of ways. In one embodiment, the single cover orfirst cover of PEEK may be introduced or applied directly over aconductive element 112 a-d through extrusion. Extrusion is the processof forming a continuous shape by applying force to a material through adie. Polymer extrusion is described, for example, in Chris Rauwendaal,pp. 1-30, 155-205, Polymer Extrusion (4^(th) ed. 2001), which isincorporated by reference in relevant part. Generally, the polymericmaterial is heated in a barrel of the extruder until it attains orexceeds its melt temperature. Thereafter, the polymeric material issimultaneously extruded through a die of the extruder over theconductive element 112 a-d while the conductive element 112 a-dcontinues to move away from the extruder and/or the conductive element112 a-d moves radially. The polymeric material then forms into a firstcover 144 (also referred to as first longitudinal element) over theconductive element 112 a-d. After formation of first cover 144, thepolymeric material is allowed to cool. There are numerous ways to coolthe polymeric material. For example, the first cover 144 can be aircooled, which is a slow cooling process. Alternatively, the first cover144 can be placed in a cool water bath. In yet another embodiment, thefirst cover 144 and the conductive element 112 a-d can be placed into acooler such as a refrigeration unit to quickly cool the polymericmaterial. The process of extruding polymeric material and allowing thepolymeric material applies to each embodiment listed below.

The cover of PEEK can have a thickness of about 0.0005 inches to about0.0015 inches. In another embodiment, the cover of extruded PEEK canpossess a thickness that ranges from about 0.00020 inches to about0.0012 inches. In yet another embodiment, the cover of PEEK has athickness of about 0.0005 inches to about 0.0020 inches. The PEEK incombination with the conductive element 112 a-d forms a compositestructure.

The composite structure is then formed into a coil shape. In oneembodiment, the composite structure is formed into a coil through, forexample, winding the conductive element 112 a, b,d over a mandrel 702, acylindrically shaped element, exemplarily depicted in FIG. 10A. Inparticular, the mandrel 702 can be a high tensile strength wire that isheld under tension (i.e. both ends of the mandrel 702 are clamped) whilethe filars of the coil are wound around the diameter of the mandrel 702.While the mandrel 702 continues to rotate or move radially, filars ofthe coil are being wound or served around mandrel 702. The filars aresimultaneously translated along mandrel 702 while being wound aboutmandrel 702. An exemplary amount of winding tension applied is about 15grams; however, it is appreciated that other amounts of winding tensionscan be used The amount of tension used can depend upon the geometryand/or the mechanical characteristics (e.g. break load or strength ofthe cable filars, yield strength of the cable filars, etc.) of the cablefilars that are to be formed. Coil winding equipment is commerciallyavailable from Accuwinder Engineering Company located in San Dimas,Calif.

The coiled conductive element 112 a, b,d can be mechanically constrainedto minimize or eliminate diametrical and/or axial expansion of thecoiled conductive element 112 a, b,d. Exemplary methods for mechanicallyconstraining the conductive element 112 a,b,d can include clamping orbonding the proximal and distal ends of 112 a,b,d to a mandrel 702 orother suitable fixture or component. The clamp(s) or clamp mechanism(s)can mechanically constrain or secure the coiled conductive element 112a,b,d against the mandrel 702, as depicted, for example, in FIG. 10 suchthat coiled conductive element 112 a,b,d will not rotate or expanddiametrically and/or axially. Exemplary clamping mechanisms can take theform of a mechanical clamp, toggle(s) or heat shrink tubing(s). Theclamping mechanism can mechanically constrain the coil conductiveelement on the mandrel and hold the coiled conductive element in placeduring subsequent operations.

In one embodiment, after the extrusion coating process and the coilingprocess, no thermal processing is performed on the coiled conductiveelement 112 a, b,d. In another embodiment, after the extrusion coatingprocess and the coiling process, thermal processing is performed on thecoiled conductive element 112 a, b,d. In still yet another embodiment,after the extrusion coating process, thermal processing is performed onthe conductive element 112 a, b,d which is thereafter followed by acoiling process to coil the conductive element 112 a, b,d. In yetanother embodiment, after the extrusion coating process, the coiledconductive element 112 a, b,d is thermal processed and can then undergoa coiling process. After coiling process, the coiled conductive element112 a, b,d undergoes a second thermal process.

The composite structure can then undergo a thermal process; however, itis appreciated that a thermal process may be unnecessary to form, forexample, a coiled cable assembly. In one embodiment, the compositestructure is placed or run through a chamber. For example, a chamber oroven, commercially available from Despatch Industries, Minneapolis,Minn., can be used to process the composite structure. In oneembodiment, the temperature in the chamber is about 130° C. to about210° C. In one embodiment, the temperature in the chamber is about 130°C. to about 210° C. The composite structure remains at this temperaturefor about 30 seconds to about 45 minutes and then is cooled to form thePEEK polymeric material and conductive element 112 a,b,d in its coiledshape. The mechanical constraint is then removed such as throughde-clamping or cutting the proximal and distal ends of the conductiveelement 112 from the mandrel.

The second embodiment listed in Table 1 involves a first and a secondcover of PEEK. First and second covers 144, 146, respectively, eachpossess a thickness of about 0.0005 inches to about 0.0015 inches ofextruded PEEK. In another embodiment, first and second covers 144, 146,respectively, each possess a thickness of about 0.00020 inches to about0.0012 inches. For this embodiment, the first cover of PEEK is formed byextruding the PEEK over a conductive element 112 a,b,d. After the firstcover 144 of PEEK has been formed, a second cover 146 is created byextruding PEEK over the first cover 144. In this embodiment, thecomposite structure, composed of the first and second covers of PEEKover the conductive element 112 a,b,d, is then formed into a coil, aspreviously described.

The third embodiment involves a first, second, and third cover 144, 146,148 of PEEK, respectively. First, second, and third covers 144, 146, 148respectively, each possess a thickness of about 0.0005 inches to about0.0015 inches of extruded PEEK. In another embodiment, first, second,and third covers 144, 146, 148 respectively, each possess a thickness ofabout 0.00020 inches to about 0.001 inches. In one embodiment, the firstcover 144 of PEEK is formed by extruding the PEEK over a conductiveelement 112 a,b,d. After the PEEK has formed or solidified, PEEK isextruded over the first cover 144 of PEEK to form a second cover 146 ofPEEK. PEEK is extruded again over the second cover 146 to form a thirdcover 148 of PEEK. The composite structure composed of the first, secondand third covers of PEEK over the conductive element 112 a,b,d is thenformed into a coil and mechanically constrained. The composite structurecan then undergo a process such as thermal annealing or stressrelieving. In one embodiment, the composite structure is placed in achamber in which thermal annealing or a stress relieving process isapplied to the composite structure. The temperature is raised to about130° C. to about 210° C. for about 30 seconds to about 30 minutes toallow the PEEK polymeric material over the conductive element 112 a,b,dto anneal or stress relieve original coil shape and encase conductiveelement 112 a,b,d. The first, second and third covers 144, 146, 148 coolover the conductive element 112 a,b,d, after which time the mechanicalconstraint is removed from conductive element 112 a,b,d.

The fourth embodiment listed in Table 1 involves a first cover 144 ofPEEK followed by a second cover 146 of ETFE. ETFE is understood to becommercially available from suppliers such as Daikin of Osaka, Japan andAsahi Glass Company of Japan; however, it is understood that forpurposes of reading Table 1, other embodiments can include e-beamcross-linked ETFE.

A first cover 144 of PEEK can possess a thickness that ranges from about0.0005 inches to about 0.0015 inches of extruded PEEK. In anotherembodiment, the first cover can possess a thickness of about 0.00020inches to about 0.0020 inches and the second cover 146 can possess athickness of about 0.00020 inches to about 0.00030 inches. In oneembodiment, the first cover 144 of PEEK is formed by extruding the PEEKover a conductive element 112 a,b,d. After the PEEK has formed, ETFE isextruded or wrapped over the first cover 144 of PEEK to form a secondcover 146 of ETFE. A composite structure is formed of the first, andsecond covers 144, 146 over the conductive element 112 a,b,d. Thecomposite structure is then formed into a coil, as previously described.In an additional embodiment, the composite structure is wound on amandrel coated with a polymer material that can thermally fuse to theouter most layer 146 of the composite structure to mechanicallyconstrain selective regions or the entire coil length.

The fifth embodiment listed in Table 1 involves a first and a secondcover 144, 146 of PEEK followed by a third cover 148 of ETFE. First andsecond covers 144, 146, respectively, each possess a thickness of about0.0005 inches to about 0.0015 inches of extruded PEEK. In anotherembodiment, first and second covers 144, 146, respectively, each possessa thickness of about 0.00020 inches to about 0.001 inches. For thisembodiment, the first cover 144 of PEEK is formed by extruding the PEEKover a conductive element 112 a,b,d. After the first cover 144 of PEEKhas been formed, a second cover 146 is formed by extruding PEEK over thefirst cover 144. The third cover 148, comprising ETFE, can then beextruded over the second cover 146. The composite structure is composedof the first, second, and third covers 144, 146, and 148, respectivelyand conductive element 112 a,b,d. The composite structure is formed intoa coil shape and then mechanically constrained, as previously described.

The composite structure can then undergo thermal annealing or stressrelieving in a chamber, as previously described. The temperature in thechamber ranges from about 130° C. to about 210° C. for about 30 secondsto about 30 minutes to allow the polymeric material to form jacket 130over conductive element 112 a,b,d, after which time the mechanicalconstraint is removed.

The sixth embodiment involves a first, second, third and a fourth cover144, 146, 148, 150. First, second, and third covers 144, 146, 148comprise PEEK whereas the fourth cover 150 comprises ETFE. First,second, and third covers 144, 146, 148 respectively, each possess athickness of about 0.0005 inches to about 0.0015 inches of extrudedPEEK. In another embodiment, first, second, and third covers 144, 146,148 respectively, each possess a thickness of about 0.00020 inches toabout 0.001 inches. For this embodiment, the first cover of PEEK isformed by extruding the PEEK over a conductive element 112 a,b,d. Afterthe first cover 144 of PEEK has been formed, a second cover 146 isformed by extruding PEEK over the first cover 144. The third cover 148,comprising PEEK, can then be extruded over the second cover 146. Thefourth cover 150, comprising ETFE, can then be extruded or wrapped overthe third cover 148. The composite structure is composed of the first,second, third, and fourth covers 144, 146, 148, 150 respectively, overthe conductive element 112 a,b,d. The composite structure is formed intoa coil shape and then mechanically constrained, as previously described.

The composite structure can then be placed into a chamber where thecomposite structure undergoes thermal annealing or stress relieving, aspreviously described. The temperature is raised to about 130° C. toabout 210° C. for about 30 seconds to about 30 minutes to allow thepolymeric material to encase conductive element 112 a,b,d. The polymericmaterial is then allowed to form a jacket 130 over the conductiveelement 112 a,b,d, after which time the mechanical constraint isremoved.

The seventh embodiment involves a first, second, a third and a fourthcover 144, 146, 148, 150. First and second covers 144, 146 comprise PEEKwhereas third and fourth covers 148, 150 comprise ETFE. Each cover 144,146, 148, and 150 respectively, can possess a thickness that ranges fromabout 0.0005 inches to about 0.0015 inches. In another embodiment, firstand second covers 144, 146, respectively, each possess a thickness ofabout 0.00020 inches to about 0.001 inches. For this embodiment, thefirst cover of PEEK is formed by extruding the PEEK over a conductiveelement 112 a,b,d. After the first cover 144 of PEEK has been formed, asecond cover 146 is formed by extruding PEEK over the first cover 144.The third cover 148, comprising ETFE, can then be extruded over thesecond cover 146. The fourth cover 148, comprising ETFE, can then beextruded over the third cover 148. The composite structure is composedof the first, second, third, and fourth covers 144, 146, 148, 150,respectively, over the conductive element 112 a,b,d. The compositestructure is formed into a coil shape and then mechanically constrained.

The composite structure can then undergo thermal annealing or stressrelieving in a chamber, as previously described. The temperature israised to about 130° C. to about 210° C. for about 30 seconds to about30 minutes to allow the polymeric material of PEEK and ETFE to formjacket 130 around conductive element 112 a,b,d, after which time themechanical constraint is removed.

The eighth embodiment listed in Table 1 involves a first cover 144 ofPEEK followed by a second cover 146 of FEP. First cover 144 of PEEK canpossess a thickness that ranges from about 0.0005 inches to about 0.0015inches of extruded PEEK. In another embodiment, first cover 144 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. After the first cover 144 of PEEK has been formed, a secondcover 146 of FEP is introduced over the first cover 144. Second cover146 can possess a thickness that ranges from about 0.00020 inches toabout 0.001 inches. The composite structure, comprised of the first andsecond covers 144, 146 over the conductive element 112 a,b,d, is formedinto a coil shape and then mechanically constrained.

Thereafter, the composite structure can undergo thermal annealing orstress relieving in a chamber, as previously described. The temperatureof the chamber is about 130° C. to about 210° C. for about 30 seconds toabout 30 minutes to allow the polymeric material to form jacket 130 overconductive element 112 a,b,d, after which time the mechanical constraintis removed.

The ninth embodiment listed in Table 1 involves a first cover 144 ofPEEK followed by a second cover 146 of PFA. First cover 144 of PEEK canpossess a thickness that ranges from about 0.0005 inches to about 0.0015inches of extruded PEEK. In another embodiment, first cover 144 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. For this embodiment, the first cover of PEEK is formed byextruding the PEEK over a conductive element 112 a,b,d. After the firstcover 144 of PEEK has been formed, a second cover 146 of PFA isintroduced over the first cover 144. Second cover 146 can possess athickness that ranges from about 0.00020 inches to about 0.001 inches. Acomposite structure is formed of the first and second covers 144, 146over the conductive element 112 a,b,d. The composite structure can thenundergo thermal annealing or stress relieving in a chamber, aspreviously described. The temperature is raised to about 130° C. toabout 210° C. for about 30 seconds to about 30 minutes to allow thepolymeric material to form jacket 130 over conductive element 112 a,b,d,after which time the mechanical constraint is removed.

The tenth embodiment listed in Table 1 relates to a jacket 130 formed ofa first, second and third covers 144, 146, 148. First cover 144 of PEEKcan possess a thickness that ranges from about 0.0005 inches to about0.0015 inches of extruded PEEK. In another embodiment, first cover 144can possess a thickness that ranges from about 0.00020 inches to about0.001 inches. For this embodiment, the first cover 144 of PEEK is formedby extruding the PEEK over a conductive element 112 a,b,d. After thefirst cover 144 of PEEK has been formed, a second cover 146 of ETFE isintroduced over the first cover 144 through extrusion or wrapping ofETFE. Second cover 146 can possess a thickness that ranges from about0.00020 inches to about 0.001 inches. A third cover 148 of FEP is thenintroduced over second cover 146 through extrusion. Third cover 144 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. A composite structure is formed of the first, second, and thirdcovers 144, 146 over the conductive element 112 a,b,d. The compositestructure is formed into a coil shape and then mechanically constrained.In another embodiment, the composite structure is wound on a mandrelcoated with a polymer material that can thermally fuse with theoutermost cover of the composite structure to mechanically constrainselected regions or the entire coil length. The thermal fuse process canbe a lower temperature to effectively fuse without affecting theintegrity of the polymer covers.

The composite structure can then undergo thermal annealing or stressrelieving in a chamber, as previously described. The temperature in thechamber is about 130° C. to about 210° C. for about 30 seconds to about30 minutes to allow the polymeric material to form jacket 130 overconductive element 112 a,b,d, after which time the mechanical constraintis removed.

The eleventh embodiment listed in Table 1 relates to a jacket 130 formedof a first, second and third covers 144, 146, 148. First cover 144 ofPEEK can possess a thickness that ranges from about 0.0005 inches toabout 0.0015 inches of extruded PEEK. In another embodiment, first cover144 can possess a thickness that ranges from about 0.00020 inches toabout 0.001 inches. First cover 144 of PEEK is formed by extruding thePEEK over a conductive element 112 a,b,d. After the first cover 144 ofPEEK has been formed, a second cover 146 of ETFE is introduced over thefirst cover 144. Second cover 146 can possess a thickness that rangesfrom about 0.00020 inches to about 0.001 inches. A third cover 148 ofPFA is introduced over the second cover 146 in which the third cover 148can possess a thickness that ranges from about 0.00020 inches to about0.001 inches. A composite structure is composed of the first, second,and third covers 144, 146, 148 respectively, over the conductive element112 a,b,d. The composite structure is formed into a coil shape and thenmechanically constrained, as previously described.

The composite structure can then undergo thermal annealing or stressrelieving in a chamber. The temperature in the chamber is about 130° C.to about 210° C. for about 30 seconds to about 30 minutes to allow thepolymeric material to form jacket 130 around conductive element 112a,b,d. Thereafter, the mechanical constraint is removed.

The twelfth embodiment listed in Table 1 relates to a jacket 130 formedof a first, second and third covers 144, 146, 148. First cover 144 ofPEEK can possess a thickness that ranges from about 0.0005 inches toabout 0.0015 inches of extruded PEEK. In another embodiment, first cover144 can possess a thickness that ranges from about 0.00020 inches toabout 0.001 inches. In one embodiment, the first cover 144 of PEEK isformed by extruding the PEEK over a conductive element 112 a,b,d. Afterthe first cover 144 of PEEK has been formed, a second cover 146 of ETFEis introduced over the first cover 144. Second cover 146 can possess athickness of about 0.00020 inches to about 0.001 inches. In anotherembodiment, second cover 146 can possess a thickness of about 0.00080inches to about 0.0020 inches. A third cover 148 of EFEP is introducedover the second cover 146 in which the third cover 148 can possess athickness that ranges from about 0.00020 inches to about 0.001 inches.The composite structure is composed of the first, second, and thirdcovers 144, 146, 148 respectively, over the conductive element 112a,b,d. The composite structure is formed into a coil shape and thenmechanically constrained and formed, as previously described.

The composite structure can then undergo thermal annealing or stressrelieving in a chamber, as previously described. The temperature in thechamber is about 130° C. to about 210° C. for about 30 seconds to about30 minutes to allow the polymeric material to form jacket 130 to coverconductive element 112 a,b,d, after which time the mechanical constraintis removed.

The thirteenth embodiment listed in Table 1 involves a first cover 144of PEEK followed by a second cover 146 of PTFE, which is extruded andnonporous. First cover 144 of PEEK can possess a thickness that rangesfrom about 0.0005 inches to about 0.0015 inches of extruded PEEK. Inanother embodiment, first cover 144 can possess a thickness that rangesfrom about 0.00020 inches to about 0.001 inches. After the first cover144 of PEEK has been formed, a second cover 146 of PTFE (extruded andnonporous) is introduced over the first cover 144. Second cover 146 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. The composite structure, comprised of the first and secondcovers 144, 146 over the conductive element 112 a,b,d, is formed into acoil shape and then mechanically constrained.

Thereafter, the composite structure undergoes thermal annealing orstress relieving in a chamber, as previously described. The temperatureof the chamber is about 130° C. to about 210° C. for about 30 seconds toabout 30 minutes to allow the polymeric material to form jacket 130 overconductive element 112 a,b,d, after which time the mechanical constraintis removed.

The fourteenth embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148. First cover144 of PEEK can possess a thickness that ranges from about 0.0005 inchesto about 0.0015 inches of extruded PEEK. In another embodiment, firstcover 144 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. First cover 144 of PEEK is formed by extrudingthe PEEK over a conductive element 112 a,b,d. After the first cover 144of PEEK has been formed, a second cover 146 of PTFE (extruded andnonporous) is introduced over the first cover 144. Second cover 146 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. A third cover 148 of FEP is introduced over the second cover 146in which the third cover 148 can possess a thickness that ranges fromabout 0.00020 inches to about 0.001 inches. A composite structure iscomposed of the first, second, and third covers 144, 146, 148respectively, over the conductive element 112 a,b,d. The compositestructure is formed into a coil shape and then mechanically constrained,as previously described.

The fifteenth embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148. First cover144 of PEEK can possess a thickness that ranges from about 0.0005 inchesto about 0.0015 inches of extruded PEEK. In another embodiment, firstcover 144 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. First cover 144 of PEEK is formed by extrudingthe PEEK over a conductive element 112 a,b,d. After the first cover 144of PEEK has been formed, a second cover 146 of PTFE (extruded andnonporous) is introduced over the first cover 144. Second cover 146 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. A third cover 148 of PFA is introduced over the second cover 146in which the third cover 148 can possess a thickness that ranges fromabout 0.00020 inches to about 0.001 inches. A composite structure iscomposed of the first, second, and third covers 144, 146, 148respectively, over the conductive element 112 a,b,d. The compositestructure is formed into a coil shape and then mechanically constrained,as previously described.

The sixteenth embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148. First cover144 of PEEK can possess a thickness that ranges from about 0.0005 inchesto about 0.0015 inches of extruded PEEK. In another embodiment, firstcover 144 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. First cover 144 of PEEK is formed by extrudingthe PEEK over a conductive element 112 a,b,d. After the first cover 144of PEEK has been formed, a second cover 146 of PTFE (extruded andnonporous) is introduced over the first cover 144. Second cover 146 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. A third cover 148 of EFEP is introduced over the second cover146 in which the third cover 148 can possess a thickness that rangesfrom about 0.00020 inches to about 0.001 inches.

A composite structure is composed of the first, second, and third covers144, 146, 148 respectively, over the conductive element 112 a,b,d. Thecomposite structure is formed into a coil shape and then mechanicallyconstrained, as previously described.

The seventeenth embodiment listed in Table 1 involves a first cover 144of PEEK followed by a second cover 146 of polyurethane. Polyurethanesuch as polyurethane grade 80A or 55D commercially available fromPolymer Technology Group (PTG) located in Berekley, Calif. First cover144 of PEEK can possess a thickness that ranges from about 0.0005 inchesto about 0.0015 inches of extruded PEEK. In another embodiment, firstcover 144 can possess a thickness that ranges from about 0.00020 inchesto about 0.0012 inches. In this embodiment, the first cover of PEEK isformed by extruding the PEEK over a conductive element 112 a,b,d. Afterthe first cover 144 of PEEK has been formed a second cover 146 ofpolyurethane is formed by extruding the polyurethane over the firstcover 144. Second cover 146 can possess a thickness of about 0.00020inches to about 0.006 inches. In another embodiment, second cover 146can possess a thickness that ranges from about 0.0010 inches to about0.0050 inches. The first and second covers 144, 146 over conductiveelement 112 a,b,d is a composite structure. The composite structure isformed into a coil shape and then mechanically constrained, aspreviously described with the exception of lower temperature being usedto form coiled structure without melting the polyurethane i.e. 150° F.or a polyurethane with a melt temperature between 40° C. to 180° C.

The eighteenth embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148. First cover144 of PEEK can possess a thickness that ranges from about 0.0005 inchesto about 0.0015 inches of extruded PEEK. In another embodiment, firstcover 144 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. For this embodiment, the first cover 144 of PEEKis formed by extruding the PEEK over a conductive element 112 a,b,d.After the first cover 144 of PEEK has been formed, a second cover 146 ofpolyurethane is introduced over the first cover 144. Second cover 146can possess a thickness that ranges from about 0.00020 inches to about0.001 inches. In another embodiment, second cover 146 can possess athickness that ranges from about 0.0010 inches to about 0.0050 inches. Athird cover 148 of FEP is extruded over the second cover 146 in whichthe third cover 148 can possess a thickness that ranges from about0.00020 inches to about 0.001 inches. The composite structure composedof the first, second, and third covers 144, 146, 148 respectively, isformed into a coil shape and then mechanically constrained.

The composite structure is then thermally annealed over the conductiveelement 112 a,b,d. The composite structure is placed into a chamber thatpossesses a temperature of about 130° C. to about 210° C. for about 30seconds to about 30 minutes. After the jacket 130 is formed, themechanical constraint is removed.

The nineteenth embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148. First cover144 of PEEK can possess a thickness that ranges from about 0.0005 inchesto about 0.0015 inches of extruded PEEK. In another embodiment, firstcover 144 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. For this embodiment, the first cover 144 of PEEKis formed by extruding the PEEK over a conductive element 112 a,b,d.After the first cover 144 of PEEK has been formed, a second cover 146 ofpolyurethane is introduced over the first cover 144. Second cover 146can possess a thickness that ranges from about 0.00020 inches to about0.001 inches. A third cover 148 of PFA is introduced over the secondcover 146 in which the third cover 148 can possess a thickness in therange of about 0.00020 inches to about 0.003 inches. The compositestructure composed of the first, second, and third covers 144, 146, 148respectively, is formed into a coil shape and then mechanicallyconstrained.

The composite structure is then thermally annealed to form jacket 130over the conductive element 112 a,b,d. The composite structure is placedinto a chamber, in which the temperature is about 130° C. to about 210°C. for about 30 seconds to about 30 minutes. Thereafter, the mechanicalconstraint is removed.

The twentieth embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148. First cover144 of PEEK can possess a thickness that ranges from about 0.0005 inchesto about 0.0015 inches of extruded PEEK. In another embodiment, firstcover 144 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. For this embodiment, the first cover 144 of PEEKis formed by extruding the PEEK over a conductive element 112 a,b,d.After the first cover 144 of PEEK has been formed, a second cover 146 ofpolyurethane is extruded over the first cover 144. Second cover 146 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. In another embodiment, second cover 146 can possess a thicknessthat ranges from about 0.0010 inches to about 0.0050 inches. A thirdcover 148 of EFEP is introduced over the second cover 146 in which thethird cover 148 can possess a thickness that ranges from about 0.00020inches to about 0.001 inches. EFEP is commercially available from Daikinlocated in Osaka, Japan. The composite structure composed of the first,second, and third covers 144, 146, 148 respectively, is formed into acoil shape and then mechanically constrained.

The composite structure is then thermally annealed over the conductiveelement 112 a,b,d. The composite structure is placed into a chamber at atemperature of about 130° C. to about 210° C. for about 30 seconds toabout 30 minutes. Thereafter, the mechanical constraint is removed.

The twenty first embodiment listed in Table 1 relates to a jacket 130formed of a first and second covers 144, 146. The twenty firstembodiment listed in Table 1 involves a first cover 144 of PEEK followedby a second cover 146 of EFEP. First cover 144 of PEEK can possess athickness that ranges from about 0.0005 inches to about 0.0015 inches ofextruded PEEK. In another embodiment, first cover 144 can possess athickness that ranges from about 0.00020 inches to about 0.002 inches.For this embodiment, the first cover of PEEK is formed by extruding thePEEK over a conductive element 112 a,b,d. After the first cover 144 ofPEEK has been formed, a second cover 146 of EFEP is introduced over thefirst cover 144. Second cover 146 can possess a thickness that rangesfrom about 0.00020 inches to about 0.001 inches. The composite structureis formed into a coil shape and then mechanically constrained.

The composite structure composed of the first and second covers 144, 146is then thermally annealed over the conductive element 112 a,b,d. Thecomposite structure is placed in a chamber with a temperature of about130° C. to about 210° C. for about 30 seconds to about 30 minutes.Thereafter, the mechanical constraint is removed.

The twenty second embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148. First cover144 of PEEK can possess a thickness that ranges from about 0.0005 inchesto about 0.0015 inches of extruded PEEK. In another embodiment, firstcover 144 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. For this embodiment, the first cover 144 of PEEKis formed by extruding the PEEK over a conductive element 112 a,b,d.After the first cover 144 of PEEK has been formed, a second cover 146 ofETFE is introduced over the first cover 144. Second cover 146 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. A third cover 148 of polyurethane-silicone copolymers isintroduced over the second cover 146 in which the third cover 148 canpossess a thickness that ranges from about 0.00020 inches to about 0.003inches. Polyurethane/silicone block copolymer is, for example,commercially available as polyurethene polydimethyl siloxane copolymeravailable as pursil from PTG; however, it understood that numerous othertrade named products can also be used. The first, second, and thirdcovers 144, 146, 148 over a conductive element 112 a,b,d is a compositestructure. The composite structure is formed into a coil shape and thenmechanically constrained.

The composite structure is then thermally annealed over conductiveelement 112 a,b,d, after which time the mechanical constraint isremoved. The composite structure is placed in a chamber with atemperature of about 130° C. to about 210° C. for about 30 seconds toabout 30 minutes. Thereafter, the mechanical constraint is removed.

The twenty third embodiment listed in Table 1 relates to a jacket 130formed of a first, second, third, and fourth covers 144, 146, 148, 150.First cover 144 of PEEK can possess a thickness that ranges from about0.0005 inches to about 0.0015 inches of extruded PEEK. In anotherembodiment, first cover 144 can possess a thickness that ranges fromabout 0.00020 inches to about 0.001 inches. For this embodiment, thefirst cover of PEEK is formed by extruding the PEEK over a conductiveelement 112 a,b,d. After the first cover 144 of PEEK has been formed, asecond cover 146 of ETFE is introduced over the first cover 144 throughextrusion. Second cover 146 can possess a thickness that ranges fromabout 0.00020 inches to about 0.001 inches. After the second cover 146has been formed, a third cover 148 of polyurethane-silicone co-polymersis introduced over the first cover 144. In another embodiment, thirdcover 148 can possess a thickness that ranges from about 0.0010 inchesto about 0.0050 inches. Third cover 148 can possess a thickness thatranges from about 0.00020 inches to about 0.003 inches. After the secondcover 146 has been formed, a N cover 150 or fourth cover of FEP isintroduced over the third cover 148. N cover 150 can possess a thicknessthat ranges from about 0.00020 inches to about 0.001 inches. The first,second, third and fourth covers 144, 146, 148, 150 over the conductiveelement 112 a,b,d is a composite structure. The composite structure isformed into a coil shape and then mechanically constrained.

The composite structure is then thermally annealed to form jacket 130over conductive element 112 a,b,d. The composite structure is placed ina chamber with a temperature for about 130° C. to about 210° C. forabout 30 seconds to about 30 minutes. Thereafter, the mechanicalconstraint is removed.

The twenty fourth embodiment listed in Table 1 relates to a jacket 130formed of a first, second, third, and fourth covers 144, 146, 148, 150.First cover 144 of PEEK can possess a thickness that ranges from about0.0005 inches to about 0.0015 inches of extruded PEEK. In anotherembodiment, first cover 144 can possess a thickness that ranges fromabout 0.00020 inches to about 0.001 inches. For this embodiment, thefirst cover of PEEK is formed by extruding the PEEK over a conductiveelement 112 a,b,d. After the first cover 144 of PEEK has been formed, asecond cover 146 of ETFE is introduced over the first cover 144. Secondcover 146 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. After the second cover 146 has been formed, athird cover 148 of polyurethane-silicone co-polymers is introduced overthe first cover 144. Third cover 148 can possess a thickness that rangesfrom about 0.00020 inches to about 0.001 inches. In another embodiment,the third cover 148 can possess a thickness that ranges from about0.0010 inches to about 0.0050 inches. After the second cover 146 hasbeen formed, a N cover 152 or fourth cover of PFA is introduced over thethird cover 150. N cover 152 can possess a thickness that ranges fromabout 0.00020 inches to about 0.001 inches. The first, second, third andfourth covers 144, 146, 148, 150 over conductive element 112 a,b,d is acomposite structure. The composite structure is formed into a coil shapeand then mechanically constrained.

The composite structure is then thermally annealed to form jacket 130over conductive element 112 a,b,d. The composite structure is placed ina chamber with a temperature for about 130° C. to about 210° C. forabout 30 seconds to about 30 minutes. Thereafter, the mechanicalconstraint is removed.

The twenty fifth embodiment listed in Table 1 relates to a jacket 130formed of a first, second, third, and fourth covers 144, 146, 148, 150.First cover 144 of PEEK can possess a thickness that ranges from about0.0005 inches to about 0.0015 inches of extruded PEEK. In anotherembodiment, first cover 144 can possess a thickness that ranges fromabout 0.00020 inches to about 0.001 inches. For this embodiment, thefirst cover of PEEK is formed by extruding the PEEK over a conductiveelement 112 a,b,d. After the first cover 144 of PEEK has been formed, asecond cover 146 of ETFE is introduced over the first cover 144. Inanother embodiment, the second cover 146 can possess a thickness thatranges from about 0.0020 inches to about 0.0030 inches. In yet anotherembodiment, the second cover 146 can possess a thickness that rangesfrom about 0.0010 inches to about 0.0050 inches. Second cover 146 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. After the second cover 146 has been formed, a third cover 148 ofpolyurethane-silicone co-polymers is introduced over the first cover144. Third cover 148 can possess a thickness that ranges from about0.00020 inches to about 0.001 inches. After the second cover 146 hasbeen formed, a N cover 152 or fourth cover of EFEP is introduced overthe third cover 150. N cover 152 can possess a thickness that rangesfrom about 0.00020 inches to about 0.001 inches. The first, second,third and fourth covers 144, 146, 148, 150 over the conductive element112 a,b,d forms a composite structure. In another embodiment, N covercan possess a thickness that ranges from about 0.0010 inches to about0.005 inches. The composite structure is formed into a coil shape andthen mechanically constrained.

The composite structure is then thermally processed to form jacket 130over conductive element 112 a,b,d. The composite structure is placed ina chamber with a temperature for about 130° C. to about 210° C. forabout 30 seconds to about 30 minutes. Thereafter, the mechanicalconstraint is removed.

The twenty sixth embodiment listed in Table 1 relates to a jacket 130formed of a first, and second covers 144, 146. First cover 144 of PEEKcan possess a thickness that ranges from about 0.0005 inches to about0.0015 inches of extruded PEEK. In another embodiment, first cover 144can possess a thickness that ranges from about 0.00020 inches to about0.001 inches. For this embodiment, the first cover 144 of PEEK is formedby extruding the PEEK over a conductive element 112 a,b,d. After thefirst cover 144 of PEEK has been formed, a second cover 146 ofpolyurethane-silicone copolymers is introduced over the first cover 144.Second cover 146 can possess a thickness that ranges from about 0.00020inches to about 0.001 inches. In another embodiment, second cover 146can possess a thickness that ranges from about 0.0010 inches to about0.0050 inches. The first, and second covers 144, 146, over theconductive element 112 a,b,d forms a composite structure. The compositestructure is then formed into a coil, as previously described.

The composite structure is then thermally annealed to form jacket 130over conductive element 112 a,b,d. The composite structure is placed ina chamber with a temperature for about 130° C. to about 210° C. forabout 30 seconds to about 30 minutes. Thereafter, the mechanicalconstraint is removed.

The twenty seventh embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148. First cover144 of PEEK can possess a thickness that ranges from about 0.0005 inchesto about 0.0015 inches of extruded PEEK. In another embodiment, firstcover 144 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. For this embodiment, the first cover 144 of PEEKis formed by extruding the PEEK over a conductive element 112 a,b,d.After the first cover 144 of PEEK has been formed, a second cover 146 ofpolyurethane-silicone copolymers is introduced over the first cover 144.Second cover 146 can possess a thickness that ranges from about 0.00020inches to about 0.001 inches. In another embodiment, the second cover146 can possess a thickness that ranges from about 0.0010 inches toabout 0.0050 inches. A third cover 148 of FEP is introduced over thesecond cover 146 in which the third cover 148 can possess a thicknessthat ranges from about 0.00020 inches to about 0.001 inches. The first,second, and third covers 144, 146, 148 over the conductive element 112a,b,d forms a composite structure. The composite structure is thenthermally annealed to form jacket 130 over conductive element 112 a,b,d.The composite structure is placed in a chamber with a temperature forabout 130° C. to about 210° C. for about 30 seconds to about 30 minutes.Thereafter, the mechanical constraint is removed.

The twenty eighth embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148. First cover144 of PEEK can possess a thickness that ranges from about 0.0005 inchesto about 0.0015 inches of extruded PEEK. In another embodiment, firstcover 144 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. For this embodiment, the first cover 144 of PEEKis formed by extruding the PEEK over a conductive element 112 a,b,d.After the first cover 144 of PEEK has been formed, a second cover 146 ofpolyurethane-silicone copolymers is introduced over the first cover 144.Second cover 146 can possess a thickness that ranges from about 0.00020inches to about 0.001 inches. In another embodiment, the third cover 148can possess a thickness that ranges from about 0.0010 inches to about0.0050 inches. A third cover 148 of PFA is introduced over the secondcover 146 in which the third cover 148 can possess a thickness thatranges from about 0.00020 inches to about 0.001 inches. The compositestructure is formed into a coil shape and then mechanically constrained.

The composite structure is then thermally annealed to form jacket 130over conductive element 112 a,b,d. The composite structure is placed ina chamber with a temperature for about 130° C. to about 210° C. forabout 30 seconds to about 30 minutes. Thereafter, the mechanicalconstraint is removed.

The twenty ninth embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148. First cover144 of PEEK can possess a thickness that ranges from about 0.0005 inchesto about 0.0015 inches of extruded PEEK. In another embodiment, firstcover 144 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. For this embodiment, the first cover 144 of PEEKis formed by extruding the PEEK over a conductive element 112 a,b,d.After the first cover 144 of PEEK has been formed, a second cover 146 ofpolyurethane-silicone copolymers is introduced over the first cover 144.Second cover 146 can possess a thickness that ranges from about 0.00020inches to about 0.001 inches. In another embodiment, the second cover146 can possess a thickness that ranges from about 0.0010 inches toabout 0.0050 inches. A third cover 148 of EFEP is introduced over thesecond cover 146 in which the third cover 148 can possess a thicknessthat ranges from about 0.00020 inches to about 0.001 inches. Thecomposite structure is formed into a coil shape and then mechanicallyconstrained.

The composite structure is then thermally annealed to form jacket 130over conductive element 112 a,b,d. The composite structure is placed ina chamber with a temperature for about 130° C. to about 210° C. forabout 30 seconds to about 30 minutes. Thereafter, the mechanicalconstraint is removed.

The thirtieth embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148. First cover144 of PEEK can possess a thickness that ranges from about 0.0005 inchesto about 0.0015 inches of extruded PEEK. In another embodiment, firstcover 144 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. For this embodiment, the first cover 144 of PEEKis formed by extruding the PEEK over a conductive element 112 a,b,d.After the first cover 144 of PEEK has been formed, a second cover 146 ofETFE is introduced over the first cover 144. Second cover 146 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. A third cover 148 of polyurethane with surface modifying endgroups (SMEs), commercially available as Pellethane® from Dow Chemicalin Midland Mich. or as Elasthane™ from PTG located in Berkley, Calif.,is introduced over the second cover 146 in which the third cover 148 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. In another embodiment, the third cover 148 can possess athickness that ranges from about 0.0010 inches to about 0.0050 inches.The first, second, and third covers 144, 146, 148 form a compositestructure. The composite structure is formed into a coil shape and thenmechanically constrained.

The composite structure is then thermally annealed to form jacket 130over conductive element 112 a,b,d. The composite structure is placed ina chamber with a temperature for about 130° C. to about 210° C. forabout 30 seconds to about 30 minutes. Thereafter, the mechanicalconstraint is removed.

The thirty first embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148, 150. Firstcover 144 of PEEK can possess a thickness that ranges from about 0.0005inches to about 0.0015 inches of extruded PEEK. In another embodiment,first cover 144 can possess a thickness that ranges from about 0.00020inches to about 0.001 inches. For this embodiment, the first cover 144of PEEK is formed by extruding the PEEK over a conductive element 112a,b,d. After the first cover 144 of PEEK has been formed, a second cover146 of ETFE is introduced over the first cover 144. Second cover 146 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. A third cover 148 of polyurethane with SME is introduced overthe second cover 146 in which the third cover 148 can possess athickness that ranges from about 0.00020 inches to about 0.004 inches.In another embodiment, the third cover 148 can possess a thickness thatranges from about 0.0010 inches to about 0.0050 inches. A N or fourthcover 150 of FEP is introduced over the third cover 148 in which thefourth cover 150 possess a thickness of about 0.00020 inches to about0.001 inches. The first, second, third and fourth covers 144, 146, 148,150 over conductive element 112 a,b,d forms a composite structure.

The composite structure is then thermally annealed to form jacket 130over conductive element 112 a,b,d. The composite structure is placed ina chamber with a temperature for about 130° C. to about 210° C. forabout 30 seconds to about 30 minutes. Thereafter, the mechanicalconstraint is removed.

The thirty second embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148, 150. Firstcover 144 of PEEK can possess a thickness that ranges from about 0.0005inches to about 0.0015 inches of extruded PEEK. In another embodiment,first cover 144 can possess a thickness that ranges from about 0.00020inches to about 0.001 inches. For this embodiment, the first cover 144of PEEK is formed by extruding the PEEK over a conductive element 112a,b,d. After the first cover 144 of PEEK has been formed, a second cover146 of ETFE is introduced over the first cover 144. Second cover 146 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. A third cover 148 of polyurethane with SME is introduced overthe second cover 146 in which the third cover 148 can possess athickness that ranges from about 0.00020 inches to about 0.001 inches. AN or fourth cover 150 of PFA is introduced over the third cover 148 inwhich the fourth cover 150 possess a thickness of about 0.00020 inchesto about 0.001 inches. The first, second, third and fourth covers 144,146, 148, 150 over the conductive element 112 a,b,d form a compositestructure. The composite structure is then thermally annealed to formjacket 130 over conductive element 112 a,b,d. The composite structure isplaced in a chamber with a temperature for about 130° C. to about 210°C. for about 30 seconds to about 30 minutes. Thereafter, the mechanicalconstraint is removed.

The thirty third embodiment listed in Table 1 relates to a jacket 130formed of a first, second, third and fourth covers 144, 146, 148, 150,respectively. First cover 144 of PEEK can possess a thickness thatranges from about 0.0005 inches to about 0.0015 inches of extruded PEEK.In another embodiment, first cover 144 can possess a thickness thatranges from about 0.00020 inches to about 0.001 inches. For thisembodiment, the first cover 144 of PEEK is formed by extruding the PEEKover a conductive element 112 a,b,d. After the first cover 144 of PEEKhas been formed, a second cover 146 of ETFE is introduced over the firstcover 144. Second cover 146 can possess a thickness that ranges fromabout 0.00020 inches to about 0.001 inches. A third cover 148 ofpolyurethane with SME is introduced over the second cover 146 in whichthe third cover 148 can possess a thickness that ranges from about0.00020 inches to about 0.001 inches. In another embodiment, the thirdcover 148 can possess a thickness that ranges from about 0.0010 inchesto about 0.0050 inches. A N or fourth cover 150 of EFEP is introducedover the third cover 148 in which the fourth cover 150 possess athickness of about 0.00020 inches to about 0.001 inches. The first,second, third and fourth covers 144, 146, 148, 150 over conductiveelement 112 a,b,d forms a composite structure. The composite structureis then thermally annealed to form jacket 130 over conductive element112 a,b,d. The composite structure is placed in a chamber with atemperature for about 130° C. to about 210° C. for about 30 seconds toabout 30 minutes. Thereafter, the mechanical constraint is removed.

The thirty fourth embodiment listed in Table 1 relates to a jacket 130formed of a first, and second covers 144, 146. First cover 144 of PEEKcan possess a thickness that ranges from about 0.0005 inches to about0.0015 inches of extruded PEEK. In another embodiment, first cover 144can possess a thickness that ranges from about 0.00020 inches to about0.001 inches. For this embodiment, the first cover 144 of PEEK is formedby extruding the PEEK over a conductive element 112 a,b,d. After thefirst cover 144 of PEEK has been formed, a second cover 146 ofpolyurethane with SME is introduced over the first cover 144. Secondcover 146 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. The first and second covers 144, 146, over theconductive element 112 a,b,d forms the composite structure. Thecomposite structure is then thermally annealed to form jacket 130 overconductive element 112 a,b,d. The composite structure is placed in achamber with a temperature for about 130° C. to about 210° C. for about30 seconds to about 30 minutes. Thereafter, the mechanical constraint isremoved.

The thirty fifth embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148. First cover144 of PEEK can possess a thickness that ranges from about 0.0005 inchesto about 0.0015 inches of extruded PEEK. In another embodiment, firstcover 144 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. For this embodiment, the first cover 144 of PEEKis formed by extruding the PEEK over a conductive element 112 a,b,d.After the first cover 144 of PEEK has been formed, a second cover 146 ofpolyurethane with SME is introduced over the first cover 144. Secondcover 146 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. A third cover 148 of FEP is introduced over thesecond cover 146 in which the third cover 148 can possess a thicknessthat ranges from about 0.00020 inches to about 0.001 inches. The first,second, and third covers 144, 146, 148 over the conductive element 112a,b,d forms a composite structure.

The composite structure is then thermally annealed to form jacket 130over conductive element 112 a,b,d. The composite structure is placed ina chamber with a temperature for about 130° C. to about 210° C. forabout 30 seconds to about 30 minutes. Thereafter, the mechanicalconstraint is removed.

The thirty sixth embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148. First cover144 of PEEK can possess a thickness that ranges from about 0.0005 inchesto about 0.0015 inches of extruded PEEK. In another embodiment, firstcover 144 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. For this embodiment, the first cover 144 of PEEKis formed by extruding the PEEK over a conductive element 112 a,b,d.After the first cover 144 of PEEK has been formed, a second cover 146 ofpolyurethane with SME is introduced over the first cover 144. Secondcover 146 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. A third cover 148 of PFA is introduced over thesecond cover 146 in which the third cover 148 can possess a thicknessthat ranges from about 0.00020 inches to about 0.001 inches. The first,second, and third covers 144, 146, 148 are then thermally annealed toform jacket 130 over conductive element 112 a,b,d, after which time themechanical constraint is removed.

The thirty seventh embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148. First cover144 of PEEK can possess a thickness that ranges from about 0.0005 inchesto about 0.0015 inches of extruded PEEK. In another embodiment, firstcover 144 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. For this embodiment, the first cover 144 of PEEKis formed by extruding the PEEK over a conductive element 112 a,b,d.After the first cover 144 of PEEK has been formed, a second cover 146 ofpolyurethane with SME is introduced over the first cover 144. Secondcover 146 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. A third cover 148 of EFEP is introduced over thesecond cover 146 in which the third cover 148 can possess a thicknessthat ranges from about 0.00020 inches to about 0.001 inches. The first,second, and third covers 144, 146, 148 are then thermally annealed toform jacket 130 over conductive element 112 a,b,d, after which time themechanical constraint is removed.

The thirty eighth embodiment listed in Table 1 relates to a jacket 130formed of a first, and second covers 144, 146. First cover 144 of PEEKcan possess a thickness that ranges from about 0.0005 inches to about0.0015 inches of extruded PEEK. In another embodiment, first cover 144can possess a thickness that ranges from about 0.00020 inches to about0.001 inches. For this embodiment, the first cover 144 of PEEK is formedby extruding the PEEK over a conductive element 112 a,b,d. After thefirst cover 144 of PEEK has been formed, a second cover 146 ofpolyurethane-silicone copolymers with SME is introduced over the firstcover 144. Second cover 146 can possess a thickness that ranges fromabout 0.00020 inches to about 0.001 inches. The first, and second covers144, 146 are then thermally annealed to form jacket 130 over conductiveelement 112 a,b,d, after which time the mechanical constraint isremoved.

The thirty ninth embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148. First cover144 of PEEK can possess a thickness that ranges from about 0.0005 inchesto about 0.0015 inches of extruded PEEK. In another embodiment, firstcover 144 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. For this embodiment, the first cover 144 of PEEKis formed by extruding the PEEK over a conductive element 112 a,b,d.After the first cover 144 of PEEK has been formed, a second cover 146 ofpolyurethane-silicone copolymers with SME is introduced over the firstcover 144. Second cover 146 can possess a thickness that ranges fromabout 0.00020 inches to about 0.001 inches. A third cover 148 of FEP isintroduced over the second cover 146 in which the third cover 148 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. The first, second, and third covers 144, 146, 148 are thenthermally annealed to form jacket 130 over conductive element 112 a,b,d,after which time the mechanical constraint is removed.

The fortieth embodiment listed in Table 1 relates to a jacket 130 formedof a first, second and third covers 144, 146, 148. First cover 144 ofPEEK can possess a thickness that ranges from about 0.0005 inches toabout 0.0015 inches of extruded PEEK. In another embodiment, first cover144 can possess a thickness that ranges from about 0.00020 inches toabout 0.001 inches. For this embodiment, the first cover 144 of PEEK isformed by extruding the PEEK over a conductive element 112 a,b,d. Afterthe first cover 144 of PEEK has been formed, a second cover 146 ofpolyurethane-silicone copolymers with SME is introduced over the firstcover 144. Second cover 146 can possess a thickness that ranges fromabout 0.00020 inches to about 0.001 inches. A third cover 148 of PFA isintroduced over the second cover 146 in which the third cover 148 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. The first, second, and third covers 144, 146, 148 are thenthermally annealed to form jacket 130 over conductive element 112 a,b,d,after which time the mechanical constraint is removed.

The forty first embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148. First cover144 of PEEK can possess a thickness that ranges from about 0.0005 inchesto about 0.0015 inches of extruded PEEK. In another embodiment, firstcover 144 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. For this embodiment, the first cover 144 of PEEKis formed by extruding the PEEK over a conductive element 112 a,b,d.After the first cover 144 of PEEK has been formed, a second cover 146 ofpolyurethane-silicone copolymers with SME is introduced over the firstcover 144. Second cover 146 can possess a thickness that ranges fromabout 0.00020 inches to about 0.001 inches. A third cover 148 of EFEP isintroduced over the second cover 146 in which the third cover 148 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. The first, second, and third covers 144, 146, 148 are thenthermally annealed to form jacket 130 over conductive element 112 a,b,d,after which time the mechanical constraint is removed.

The forty second embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148. First cover144 of PEEK can possess a thickness that ranges from about 0.0005 inchesto about 0.0015 inches of extruded PEEK. In another embodiment, firstcover 144 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. For this embodiment, the first cover of PEEK isformed by extruding the PEEK over a conductive element 112 a,b,d. Afterthe first cover 144 of PEEK has been formed, a second cover 146 of ETFEis introduced over the first cover 144. Second cover 146 can possess athickness that ranges from about 0.00020 inches to about 0.001 inches. Athird cover 148 of silicone is then introduced over second cover 146.Third cover 144 can possess a thickness that ranges from about 0.00020inches to about 0.001 inches. The first, second, and third covers 144,146, 148 are then thermally annealed to form jacket 130 over conductiveelement 112 a,b,d, after which time the mechanical constraint isremoved.

The forty third embodiment listed in Table 1 relates to a jacket 130formed of a first, second, third and fourth covers 144, 146, 148, 150.First cover 144 of PEEK can possess a thickness that ranges from about0.0005 inches to about 0.0015 inches of extruded PEEK. In anotherembodiment, first cover 144 can possess a thickness that ranges fromabout 0.00020 inches to about 0.001 inches. For this embodiment, thefirst cover 144 of PEEK is formed by extruding the PEEK over aconductive element 112 a,b,d. After the first cover 144 of PEEK has beenformed, a second cover 146 of ETFE is introduced over the first cover144. Second cover 146 can possess a thickness that ranges from about0.00020 inches to about 0.001 inches. A third cover 148 of silicone isintroduced over the second cover 146 in which the third cover 148 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. A fourth cover 150 of FEP is introduced over the second cover146 in which the fourth cover 150 can possess a thickness that rangesfrom about 0.00020 inches to about 0.001 inches. The first, second, andthird covers 144, 146, 148 are then thermally annealed to form jacket130 over conductive element 112 a,b,d, after which time the mechanicalconstraint is removed.

The forty fourth embodiment listed in Table 1 relates to a jacket 130formed of a first, second, third and fourth covers 144, 146, 148, 150.First cover 144 of PEEK can possess a thickness that ranges from about0.0005 inches to about 0.0015 inches of extruded PEEK. In anotherembodiment, first cover 144 can possess a thickness that ranges fromabout 0.00020 inches to about 0.001 inches. For this embodiment, thefirst cover 144 of PEEK is formed by extruding the PEEK over aconductive element 112 a,b,d. After the first cover 144 of PEEK has beenformed, a second cover 146 of ETFE is introduced over the first cover144. Second cover 146 can possess a thickness that ranges from about0.00020 inches to about 0.001 inches. A third cover 148 of silicone isintroduced over the second cover 146 in which the third cover 148 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. A fourth cover 148 of PFA is introduced over the second cover146 in which the third cover 148 can possess a thickness that rangesfrom about 0.00020 inches to about 0.001 inches. The first, second,third and fourth covers 144, 146, 148, 150 are then thermally annealedto form jacket 130 over conductive element 112 a,b,d, after which timethe mechanical constraint is removed.

The forty fifth embodiment listed in Table 1 relates to a jacket 130formed of a first, second, third and fourth covers 144, 146, 148, 150.First cover 144 of PEEK can possess a thickness that ranges from about0.0005 inches to about 0.0015 inches of extruded PEEK. In anotherembodiment, first cover 144 can possess a thickness that ranges fromabout 0.00020 inches to about 0.001 inches. For this embodiment, thefirst cover 144 of PEEK is formed by extruding the PEEK over aconductive element 112 a,b,d. After the first cover 144 of PEEK has beenformed, a second cover 146 of ETFE is introduced over the first cover144. Second cover 146 can possess a thickness that ranges from about0.00020 inches to about 0.001 inches. A third cover 148 of silicone isintroduced over the second cover 146 in which the third cover 148 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. A fourth cover 150 of EFEP is introduced over the third cover148 in which the fourth cover 150 can possess a thickness that rangesfrom about 0.00020 inches to about 0.001 inches. The first, second,third and fourth covers 144, 146, 148, 150 are then thermally annealedto form jacket 130 over conductive element 112 a,b,d, after which timethe mechanical constraint is removed.

The forty sixth embodiment listed in Table 1 relates to a jacket 130formed of a first, and second covers 144, 146. First cover 144 of PEEKcan possess a thickness that ranges from about 0.0005 inches to about0.0015 inches of extruded PEEK. In another embodiment, first cover 144can possess a thickness that ranges from about 0.00020 inches to about0.001 inches. For this embodiment, the first cover 144 of PEEK is formedby extruding the PEEK over a conductive element 112 a,b,d. After thefirst cover 144 of PEEK has been formed, a second cover 146 of siliconeis introduced over the first cover 144. Second cover 146 can possess athickness that ranges from about 0.00020 inches to about 0.001 inches.The first, second, and third covers 144, 146, 148 are then thermallyannealed to form jacket 130 over conductive element 112 a,b,d, afterwhich time the mechanical constraint is removed.

The forty seventh embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148. First cover144 of PEEK can possess a thickness that ranges from about 0.0005 inchesto about 0.0015 inches of extruded PEEK. In another embodiment, firstcover 144 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. For this embodiment, the first cover 144 of PEEKis formed by extruding the PEEK over a conductive element 112 a,b,d.After the first cover 144 of PEEK has been formed, a second cover 146 ofsilicone is introduced over the first cover 144. Second cover 146 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. A third cover 148 of FEP is introduced over the second cover 146in which the third cover 148 can possess a thickness that ranges fromabout 0.00020 inches to about 0.001 inches. The first, second, and thirdcovers 144, 146, 148 are then thermally annealed to form jacket 130 overconductive element 112 a,b,d, after which time the mechanical constraintis removed.

The forty eighth embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148. First cover144 of PEEK can possess a thickness that ranges from about 0.0005 inchesto about 0.0015 inches of extruded PEEK. In another embodiment, firstcover 144 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. For this embodiment, the first cover 144 of PEEKis formed by extruding the PEEK over a conductive element 112 a,b,d.After the first cover 144 of PEEK has been formed, a second cover 146 ofsilicone is introduced over the first cover 144. Second cover 146 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. A third cover 148 of PFA is introduced over the second cover 146in which the third cover 148 can possess a thickness that ranges fromabout 0.00020 inches to about 0.001 inches. The first, second, and thirdcovers 144, 146, 148 are then thermally annealed to form jacket 130 overconductive element 112 a,b,d, after which time the mechanical constraintis removed.

The forty ninth embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148. First cover144 of PEEK can possess a thickness that ranges from about 0.0005 inchesto about 0.0015 inches of extruded PEEK. In another embodiment, firstcover 144 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. For this embodiment, the first cover 144 of PEEKis formed by extruding the PEEK over a conductive element 112 a,b,d.After the first cover 144 of PEEK has been formed, a second cover 146 ofsilicone is introduced over the first cover 144. Second cover 146 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. A third cover 148 of EFEP is introduced over the second cover146 in which the third cover 148 can possess a thickness that rangesfrom about 0.00020 inches to about 0.001 inches. The first, second, andthird covers 144, 146, 148 are then thermally annealed to form jacket130 over conductive element 112 a,b,d, after which time the mechanicalconstraint is removed.

The fiftieth embodiment listed in Table 1 relates to a jacket 130 formedof a first, and second covers 144, 146. First cover 144 of PEEK canpossess a thickness that ranges from about 0.0005 inches to about 0.0015inches of extruded PEEK. In another embodiment, first cover 144 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. For this embodiment, the first cover 144 of PEEK is formed byextruding the PEEK over a conductive element 112 a,b,d. After the firstcover 144 of PEEK has been formed, a second cover 146 of polyvinylidenefluoride (PVDF) is introduced over the first cover 144. Second cover 146can possess a thickness that ranges from about 0.00020 inches to about0.001 inches. The first, and second covers 144, 146 are then thermallyannealed to form jacket 130 over conductive element 112 a,b,d, afterwhich time the mechanical constraint is removed.

The fifty first embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148. First cover144 of PEEK can possess a thickness that ranges from about 0.0005 inchesto about 0.0015 inches of extruded PEEK. In another embodiment, firstcover 144 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. For this embodiment, the first cover 144 of PEEKis formed by extruding the PEEK over a conductive element 112 a,b,d.After the first cover 144 of PEEK has been formed, a second cover 146 ofPEEK is introduced over the first cover 144. Second cover 146 canpossess a thickness that ranges from about 0.00020 inches to about 0.001inches. A third cover 148 of PVDF is introduced over the second cover146 in which the third cover 148 can possess a thickness that rangesfrom about 0.00020 inches to about 0.001 inches. The first and secondcovers 144, 146 are then thermally annealed to form jacket 130 overconductive element 112 a,b,d.

The fifty second embodiment listed in Table 1 relates to a jacket 130formed of a first, second, third and fourth covers 144, 146, 148, 150.First cover 144 of PEEK can possess a thickness that ranges from about0.0005 inches to about 0.0015 inches of extruded PEEK. In anotherembodiment, first cover 144 can possess a thickness that ranges fromabout 0.00020 inches to about 0.001 inches. For this embodiment, thefirst cover 144 of PEEK is formed by extruding the PEEK over aconductive element 112 a,b,d. After the first cover 144 of PEEK has beenformed, a second cover 146 of PEEK is extruded over the first cover 144.Second cover 146 can possess a thickness that ranges from about 0.00020inches to about 0.001 inches. A third cover 148 of PVDF is introducedover the second cover 146 in which the third cover 148 can possess athickness that ranges from about 0.00020 inches to about 0.001 inches. Afourth cover 150 of PVDF is introduced over the third cover 148 in whichthe fourth cover 150 can possess a thickness that ranges from about0.00020 inches to about 0.001 inches. The first, second, third andfourth covers 144, 146, 148, 150 are then thermally processed (e.g.annealed etc.) to form jacket 130 over conductive element 112 a,b,d,after which time the mechanical constraint is removed.

The fifty third embodiment listed in Table 1 relates to a jacket 130formed of a first, second and third covers 144, 146, 148. First cover144 of PEEK can possess a thickness that ranges from about 0.0005 inchesto about 0.0015 inches of extruded PEEK. In another embodiment, firstcover 144 can possess a thickness that ranges from about 0.00020 inchesto about 0.001 inches. For this embodiment, the first cover 144 of PEEKis formed by extruding the PEEK over a conductive element 112 a,b,d.After the first cover 144 of PEEK has been formed, a second cover 146 ofPVDF is extruded over the first cover 144. Second cover 146 can possessa thickness that ranges from about 0.00020 inches to about 0.001 inches.A third cover 148 of PVDF is introduced over the second cover 146 inwhich the third cover 148 can possess a thickness that ranges from about0.00020 inches to about 0.001 inches. The first and second covers 144,146 are then thermally annealed to form jacket 130 over conductiveelement 112 a,b,d.

Table 1, presented below, summarizes the various embodiments of jacket130.

TABLE 1 Embodiments of jacket 130 that comprise one or more polymericcompounds No. First Cover Second Cover Third Cover N Cover 1 PEEK 2 PEEKPEEK 3 PEEK PEEK PEEK 4 PEEK ETFE 5 PEEK PEEK ETFE 6 PEEK PEEK PEEK ETFE7 PEEK PEEK ETFE ETFE 8 PEEK FEP 9 PEEK PFA 10 PEEK ETFE FEP 11 PEEKETFE PFA 12 PEEK ETFE EFEP 13 PEEK PTFE (extruded, nonporous) 14 PEEKPTFE (extruded, FEP nonporous) 15 PEEK PTFE (extruded, PFA nonporous) 16PEEK PTFE (extruded, nonporous) EFEP 17 PEEK Polyurethane 18 PEEKPolyurethane FEP 19 PEEK Polyurethane PFA 20 PEEK Polyurethane EFEP 21PEEK EFEP 22 PEEK ETFE Polyurethane- silicone copolymers 23 PEEK ETFEPolyurethane- FEP silicone copolymers 24 PEEK ETFE Polyurethane- PFAsilicone copolymers 25 PEEK ETFE Polyurethane- EFEP silicone copolymers26 PEEK Polyurethane- silicone copolymers 27 PEEK Polyurethane- FEPsilicone copolymers 28 PEEK Polyurethane- PFA silicone copolymers 29PEEK Polyurethane- EFEP silicone copolymers 30 PEEK ETFE Polyurethanewith SME 31 PEEK ETFE Polyurethane FEP with SME 32 PEEK ETFEPolyurethane PFA with SME 33 PEEK ETFE Polyurethane EFEP with SME 34PEEK Polyurethane with SME 35 PEEK Polyurethane FEP with SME 36 PEEKPolyurethane PFA with SME 37 PEEK Polyurethane EFEP with SME 38 PEEKPolyurethane- silicone copolymers with SME 39 PEEK Polyurethane- FEPsilicone copolymers with SME 40 PEEK Polyurethane- PFA silicone co-polymers with SME 41 PEEK Polyurethane- EFEP silicone co- polymers withSME 42 PEEK ETFE Silicones 43 PEEK ETFE Silicones FEP 44 PEEK ETFESilicones PFA 45 PEEK ETFE Silicones EFEP 46 PEEK Silicones 47 PEEKSilicones FEP 48 PEEK Silicones PFA 49 PEEK Silicones EFEP 50 PEEK PVDF51 PEEK PEEK PVDF 52 PEEK PEEK PVDF PVDF 53 PEEK PVDF PVDF

The insulated conductive element formed through jacket 130 overconductive element 112 a,b,d can be helically wrapped around a mandrel(not shown). After winding the insulated cable onto the mandrel andmechanically restraining this composite structure, the polymericmaterial over the conductive element (e.g. cable etc.) can be annealedto minimize springback and allow the conductive element (e.g. cableetc.) to retain its coiled shape. After being removed from the mandrel,the conductive element (e.g. cable etc.) retains its coiled shape.

Insulated conductive element 200 is depicted in FIGS. 5A-5B. Insulatedconductive element 200 includes a conductive element 112 a,b,d (i.e.cable, coiled cable etc.) with a thin polymeric material 204 or coverthat has been thermally processed (e.g. annealed etc.) to conductiveelement 112 a,b,d. Polymeric material 204 comprises a first and secondcovers 124 a,124 b. Conductive element 112 a,b,d has an outer diameterof about 0.09 inches or less. In one embodiment, conductive element 112a,b,d can be a 1×19 cable construction with filaments composed ofMP35N/Ag core.

Referring to FIGS. 6A-6B, an insulated conductive element 300 isdepicted that comprises a set of conductors 302 a-c (i.e. threeconductors) and an insulative layer or cover 304. Conductive element 300such as a 1×19 cable MP35N/Ag core and has an outer diameter of about0.055 inches. Insulative layer 304 comprises a layer of PEEK and a layerof ETFE. In one embodiment, each layer of PEEK and ETFE is about 0.0008inches or less. In another embodiment, each layer of PEEK and ETFE isabout 0.002 inches or less.

Referring to FIG. 7A-7B, insulated conductive element 400 comprises aset of conductors 402 a-e (i.e. five conductors) and an insulative layeror cover 404. Conductive element 400 has an outer diameter of about0.060 inches and is a 1×19 cable. Insulative layer 404 comprises a layerof PEEK and a layer of ETFE. In one embodiment, each layer of PEEK andETFE is about 0.0008 inches or less. In another embodiment, each layerof PEEK and ETFE is about 0.002 inches or less.

Referring to FIGS. 8A-8C, jacketed conductive element 500 is shown asretaining its coiled shape despite being stretched. Conductive element500 comprises a 1×19 cable construction with filaments composed ofMP35N/Ag core with an insulative or jacketed layer, coating or cover.The insulative layer comprises a layer of PEEK and a layer of ETFE. Inone embodiment, each layer of PEEK and ETFE is about 0.0008 inches orless. In one embodiment, each layer of PEEK and ETFE is about 0.002inches or less. Referring to FIG. 8A, insulated conductive element 500is depicted in a relaxed position (FIG. 8A) over a mandrel. While overthe mandrel, conductive element 500 is thermally annealed. Referring toFIG. 8B, insulated conductive element 500 is depicted in a stretchedposition. Thereafter, insulated conductive element 500 moves to arelaxed position after being stretched (FIG. 8C). The insulatedconductive element 500 retains 99% or more of its original coiled shape.In another embodiment, insulated conductive element 500 comprises 95% ormore of its original coiled shape.

Referring to FIG. 9, insulated conductive element 600 is helicallywrapped around a coil liner 130. Insulated conductive element 600comprises a set of jacketed conductors 602 (i.e. five conductorscable-coil). Referring to FIG. 10A-10B, insulated conductive element 700is helically wrapped around a mandrel 702. Insulated conductive element700 comprises a set of conductors 702 (i.e. five conductors) and aninsulative layer or cover.

FIG. 11 is a flow diagram of an exemplary computer-implemented method ora manual process to form at least one cover of PEEK over the conductiveelement. At block 800, a counter, x, is initiated to 1 in order to countthe number polymer covers formed over a conductive element. At block810, a polymer is extruded (also referred to as introduced) over theconductive element. Polymers with high elastic modulus (i.e. stiffness)such as PEEK are preferred since PEEK can be annealed or stress relievedto increase crystallinity and set the coil shape in conductive element112 a-c. At block 820, the polymer cover can undergo an optional thermalprocess.

At block 830, the counter, X, is incremented by adding 1 to the previousvalue of X. At block 840, a determination is made as to whether asufficient number of polymer covers have been formed over the conductiveelement. In this embodiment, a determination is made as to whether X=Nwhere N equals the number of pre-selected covers to be added to theconductive element. If X does not equal N, the process control returnsto block 810 to extrude the same or different polymer over the previouspolymer cover. If x does equal N, then the process goes to block 850,where the jacketed conductive element undergoes coiling, as previouslydescribed. If x does not equal N, the process returns to introducinganother polymeric cover over the conductive element 112 a-d. If x doesequal N, no additional polymer covers are introduced over the conductiveelement 112 a-d. At block 850, the jacketed conductive element is formedinto a coil. At block 860, the coiled jacketed conductive element canundergo an optional thermal process. If the method is implemented on acomputer, the number of polymeric covers formed over the conductiveelement and/or the types of polymeric material used for each cover canbe displayed on a graphical user interface of a computer. Thecomputer-implemented instructions are executed on a processor of acomputer.

Numerous alternative embodiments can be implemented using the principlesdescribed herein. In one embodiment, the single cover of PEEK may beintroduced or applied directly over a mandrel (not shown) throughextrusion. A mandrel is a cylindrically shaped body with an outerdiameter that ranges from about 10 mil to about 30 mil; however, it isto be appreciated that the range can be modified depending upon thedesired coil diameter. The mandrel is coated with a material to easilyrelease a jacket 130 formed from a polymeric compound. PEEK covers themandrel which forms a jacket 130 with an inner lumen that possessesabout the same or similar ranges as the outer diameter of the mandrel.After jacket 130 can then be strung through a lumen of another jacket130.

Additionally, while an extrusion process can produce a continuouslongitudinal tube, PEEK can also be extruded into sheets that could belaminated with an adhesive (e.g. ETFE, FEP, PFA, EFEP etc.) and slitinto rolls of tape which could subsequently be wrapped on an mandrel,cable etc. to produce multilayer insulation tubes or “covers”.

PEEK can also be molded instead of extruded. Optionally, a secondarymachining process could be used to drill-out or otherwise produce alumen to form the longitudinal tube. Filaments of PEEK can be used toproduce high strength mono or multi-filament fibers, e.g. for a “tensilelock” feature in the lumen of a coil. Filaments of PEEK can also be usedto produce braids or other reinforcing structures. In yet anotherembodiment, an adhesive (e.g. FEP etc.) (not shown) is placed betweenone or more covers 144, 146, 148, 150, 152.

In another embodiment, the single cover or first cover of PEEK can beintroduced or applied directly over a conductive element 112 a,b,dthrough, for example, a multiple-layer tape wrapping or other filmwrapping process, using a suitable adhesive or thermal bonding processto enable coupling between each layer of tape or film.

In one embodiment, PEEK may be extruded or wrapped over a mandrel.Jacket 130 is then removed from the mandrel. A jacket 130 that comprisesPEEK can be used to house a conductive element 112 c, a delivery device(e.g. stylet, guidewire etc.) or another suitable device. If jackethouses a conductive element 112 a-c, the conductive element 112 c isinserted into jacket 130. The insulated conductive element is thenwrapped around the polymeric porous layer of the mandrel. In oneembodiment, the conductive element is helically wrapped around themandrel. In one embodiment, a jacketed conductive element that is notcoiled and shape set, i.e. the coil liner, can still undergo a thermalprocess such as annealing process to increase crystallinity andresulting mechanical properties.

In another embodiment for constraining coiled conductive element 112 a,b,d, the coiled conductive element 112 a, b,d can be mechanicallyconstrained by adhesively bonding the proximal and distal ends of thecable filars to each other or to the mandrel itself. Exemplary adhesivecan include silicones, urethanes, flouropolymers etc. Selectivelyadhesively bonding between filars of a coiled conductive element 112a,b,d and/or to the mandrel itself can include placing adhesives atcertain points along the conductive element 112 a,b,d or a continuouspath along the conductive element 112 a,b,d. It can be appreciated thatadhesives used could include those activated via thermal, UV light,chemical and solvent-based methods.

In another embodiment, selectively adhesively bonding coiled conductiveelement 112 a,b,d (i.e. covered cable filars) to a polymeric coatedmandrel (e.g. a silver plated copper mandrel or wire). The polymerselected for the mandrel can be selected from Table 1. The coating onthe mandrel can form the inner insulation or coil liner. There are alsonumerous embodiments related to mechanically constraining the coilduring subsequent processing or bonding the coiled conductive element112 or coiled conductor to the mandrel. For example, the outermostinsulation (ETFE, Silicone, Pursil, Pur or combination thereof) on amandrel, can be wound to adhere the coil or conductive element 112 a-dto the mandrel on ends or in select regions. Heat processing can then beapplied to help the coil composite structure to form a more permanent orstable coiled shape.

In yet another embodiment, the coiled cable mandrel assembly is placedinto an overlay tubing and then released. This embodiment reducesdiametric expansion that may occur with coil springback. Additionally,each polyurethane embodiment listed in Table 1 can have a coverthickness that ranges from about 0.001 to about 0.005 inches. It can beappreciated that in all embodiments which employ an outermost polymercover that has a lower melting point than PEEK, thermal fusing of thecomposite coiled structure (i.e. coated cable filars) can beaccomplished at lower temperatures (such as at, or near, the meltingpoint such as within 10 degrees ° F. of the melting point for theoutermost polymer cover. This approach can result in mechanicallyconstraining selective regions along conductors 112 a,b,d. These lowertemperatures can be used to effectively fuse filars to each otherthereby affecting the integrity of the PEEK and other covers withrelatively high melting points.

In another embodiment, coils can be formed without a mandrel using wireguide equipment, commercially available from Simco Spring MachineryCompany located in Tapei, Taiwan. While at least one exemplaryembodiment has been presented in the foregoing detailed description ofthe invention, it should be appreciated that a vast number of variationsexist. For example, the conductive element 112 c such as the inner coilfilars, depicted in FIG. 3A, can be jacketed. Listed below are relatedU.S. patent applications that describe various improvements to themethods and devices of the invention described herein. Each of thesepatent applications are incorporated by reference in their entirety.

Co-pending U.S. patent application Ser. No. ______ entitled “MEDICALELECTRICAL LEAD” (Attorney docket number P0030357.00) filed by GregoryA. Boser and Kevin R. Seifert and assigned to the same Assignee as thepresent invention. This co-pending application is hereby incorporatedherein by reference in its entirety.

Co-pending U.S. patent application Ser. No. ______ entitled “MEDICALELECTRICAL LEAD” (Attorney docket number P0033694.00) filed by GregoryA. Boser and Kevin R. Seifert and assigned to the same Assignee as thepresent invention. This co-pending application is hereby incorporatedherein by reference in its entirety.

Co-pending U.S. patent application Ser. No. ______ entitled “MEDICALELECTRICAL LEAD” (Attorney docket number P0033696.00) filed by GregoryA. Boser and Kevin R. Seifert and assigned to the same Assignee as thepresent invention. This co-pending application is hereby incorporatedherein by reference in its entirety.

The description of the invention is merely exemplary in nature and,thus, variations that do not depart from the gist of the invention areintended to be within the scope of the invention. Such variations arenot to be regarded as a departure from the spirit and scope of theinvention.

1. A medical electrical lead comprising: a lead body that comprises oneor more jacketed conductive elements; wherein the jacket comprises oneor more covers, a first cover of extruded polyether ketone (PEEK)directly contacts at least one conductive element.
 2. The medicalelectrical lead of claim 1 wherein the at least one conductive elementbeing a cabled coil that retains up to 99% of its coiled shape.
 3. Themedical electrical lead of claim 1 wherein the at least one conductiveelement being a cabled coil that retains up to 95% of its coiled shape.4. The medical electrical lead of claim 1 wherein the at least oneconductive element being a cabled coil that retains up to 90% of itscoiled shape.
 5. The medical electrical lead of claim 1 wherein the atleast one conductive element being a cabled coil that retains up to 85%of its coiled shape.
 6. The medical electrical lead of claim 1 whereinthe at least one conductive element being a cabled coil that retains upto 80% of its coiled shape.
 7. The medical electrical lead of claim 1further comprising: a second cover of polymeric material coupled to thefirst cover, the second cover comprises one ofPEEK/ethylene-tetrafluoroethylene (ETFE), PVDF/ETFE, ETFE, silicone,fluorinated ethylene propylene (FEP), perfluoroalkoxy (PFA), andperfluorinated ethylene propylene (EFEP).
 8. The medical electrical leadof claim 1 further comprising: a third cover of polymeric materialcoupled to the first cover, the second cover comprises one of PEEK/ETFE,PVDF/ETFE, ETFE, silicone, FEP, PFA, and EFEP.
 9. A method of insulatinga conductive element in a medical electrical lead comprising:introducing a polymeric material over at least one conductive element;coupling the at least one conductive element around a mandrel to form acoil shape in the at least one conductive element; annealing thepolymeric material over the at least one conductive element; setting acoiled shape in the conductive element; and removing the at least oneconductive element from the mandrel.
 10. The method of claim 9, whereinthe polymeric material includes one of PEEK, and ETFE.
 11. The method ofclaim 9, wherein the at least one conductive element being a cabled coilthat retains up to 99% of its coiled shape.
 12. A method of insulating aconductive element in a medical electrical lead comprising: introducinga polymeric material over at least one conductive element; wrapping theat least one conductive element around a coil liner; annealing thepolymeric material over the at least one conductive element; and settinga coiled shape in the conductive element.
 13. A method of insulating aconductive element in a medical electrical lead comprising: introducinga polymeric material over at least one conductive element; wrappinghelically the at least one conductive element around a mandrel; couplingthe polymeric material over the at least one conductive element; andsetting a coiled shape in the conductive element.
 14. The method ofclaim 13, wherein coupling the polymeric material over the at least oneconductive element includes a shape-setting polymeric material, andthermally bonding the polymeric material to the at least one conductiveelement.
 15. The method of claim 13, wherein coupling the polymericmaterial over the at least one conductive element includes shape settingpolymeric material and then adhesively bonding the polymeric material toan underlying structure.
 16. The method of claim 13, wherein couplingthe polymeric material over the at least one conductive element includesshape setting polymeric material and then thermally bonding selectivelyat points along a length of an assembled structure.
 17. The method ofclaim 13, wherein coupling the polymeric material over the at least oneconductive element includes shape setting polymeric material and thenadhesively bonding selectively at points along a length of an assembledstructure.
 18. The method of claim 13, wherein coupling the polymericmaterial over the at least one conductive element includes shape settingpolymeric material and then thermally bonding a lower melting pointsecond polymeric material previously introduced over a first polymericmaterial.
 19. The method of claim 18, wherein the second polymericmaterial being of a lower strength and lower elongation than the firstpolymeric material.
 20. The method of claim 18, wherein the first andthe second polymeric materials are coupled with a weakly bondedinterface.
 21. The method of claim 18, wherein the first polymericmaterial being treated to promote a weakly bonded interface when coupledto the second polymeric material.
 22. The method of claim 21, whereintreated includes one of plasma and a chemical treatment.
 23. The methodof claim 13, wherein coupling includes mechanically constraining theconductive elements with one of an outer tubular material and component.24. A method of insulating a conductive element in a medical electricallead comprising: introducing a polymeric material over at least oneconductive element; wrapping helically the at least one conductiveelement around a coil liner; coupling the polymeric material over the atleast one conductive element; and setting a coiled shape in theconductive element.
 25. The method of claim 25 wherein the PEEK beingone of thermally annealed and stress relieved.
 26. A method ofinsulating a conductive element in a medical electrical lead comprising:introducing a polymer over at least one conductive element to form ajacketed conductive element; coiling the jacketed conductive element;annealing the jacketed conductive element; and setting a coiled shape inthe jacketed conductive element.
 27. The method of claim 26, wherein thecoiled shape being permanently set in the jacketed conductive element.